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RecruitingNCT06425406Updated Dec 1, 2025

Application of HFNC for the Prevention of Hypoxemia During Perioperative Anesthetic-induced Intubation in Children: A Randomized Controlled Clinical Trial

An interventional study of high-flow nasal cannula in High-flow Nasal Cannula, Children and Pre-oxygenation, sponsored by Henan Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 2 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-01.

Sponsored by Henan Provincial People's Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
2 Years to 10 Years
Sex
All
01

Study summary

Compared with adults, children have higher metabolic needs, and the airway is more likely to collapse. Before tracheal intubation after anesthesia induction, the patient 's spontaneous breathing completely disappears. At this critical stage, the residual oxygen of the lung is consumed, resulting in hypoxemia and atelectasis. Therefore, it is necessary to explore the best oxygenation strategy during intubation. In addition, ultrasound has become a common equipment in the operating room. It has the advantages of portability, repeatability, and no radiation, and can provide strong support for the diagnosis of gastric distension.

Read the detailed description

At present, hypoxia is still the main cause of complications and death during perioperative period. Compared with adults, children have lower functional residual volume and lower tolerance to hypoxia caused by apnea due to their special physiological and functional characteristics. During anesthesia induction and tracheal intubation, spontaneous breathing completely disappears. At this critical stage, hypoxemia is prone to occur, which in turn causes various serious complications. Mask ventilation may occur mask ventilation difficulties and flatulence ; since the introduction of nasal high-flow oxygen therapy ( HFNC ) into the operating room in 2015, its oxygenation method has been shown to be able to significantly improve blood oxygen when used alone in pre-oxygenation. When tracheal intubation is performed, HFNC can still maintain ventilation in the patient 's nose, so HFNC can combine the advantages of both masks to perform pre-oxygenation. There are few studies on the effect of HFNC on apnea oxygenation in children in the operating room.

02

Conditions studied

  • High-flow Nasal Cannula
  • Children
  • Pre-oxygenation
03

In context

Lead sponsor

Henan Provincial People's Hospital is the lead sponsor of 63 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 2-10 years old;
  • American Society of Anesthesiologists (ASA) Level I or II;
  • Children with healthy lungs and hearts;
  • Clear headed and able to cooperate with anesthesiologists for treatment.

Exclusion criteria

Exclusion Criteria:

  • Contraindications for HFNC: (1) Complete obstruction of the upper respiratory tract; (2) Skull base fracture or nasal bone fracture; (3) Patients who refuse to use HFNC;
  • The American Society of Anesthesiologists (ASA) rating is greater than Level II;
  • Children with upper respiratory tract infections within 2 weeks;
  • Pulmonary dysfunction, congenital heart disease in children;
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Group HFNC

    In the HFNC group, the mask ventilation was performed after the patient lost spontaneous breathing until the end-tidal oxygen concentration reached 90 %. The mask was removed and HFNC ( AIRVO2, Fisher Parker Medical Company, Auckland, New Zealand ) was used to record the patient 's safe apnea time. After the end of positive pressure ventilation, intubation or laryngeal mask placement was performed after the end-tidal oxygen concentration reached 90 % or more. During the intubation or placement of the laryngeal mask, the HFNC nasal catheter was kept in the patient 's nose for apnea oxygenation.

    Device: high-flow nasal cannula

  • No intervention
    Group control

    No intervention

Interventions

  • Devicehigh-flow nasal cannula

    In group H, mask ventilation was performed after the patient lost spontaneous breathing until the end-expiratory oxygen concentration reached 90 %. The lower mask was taken and HFNC was used to record the patient 's safe apnea time.

06

What researchers measure

Primary outcomes

  1. Apnoea time

    Investigators will record the time of oxygen saturation drop to 95 % during intubation.

    Time frame: 2-10min

07

Study locations

1 of 1 sites recruiting
  • Department of Anaesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital
    Zhengzhou, Henan, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06425406
Lead sponsor
Henan Provincial People's Hospital
Responsible party
Sponsor
First posted
May 22, 2024
Start date
Jun 15, 2024
Primary completion
Nov 30, 2025 (estimated)
Completion
Nov 30, 2025 (estimated)
Last update
Dec 1, 2025

Study contacts

KuangYu Zhao
Contact
844523078@qq.com
+8613251535857
Jun Zhou, PHD
Contact
zhoujun@zzu.edu.cn
+8613592582222
Jun Zhou, PHD
study chair · Henan Provincial People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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